On September 22, 2025 CatalYm , a world-leader in neutralizing GDF-15 in cancer and cachexia, reported two upcoming oral presentations highlighting the company’s lead-candidate visugromab at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, being held October 17th-21st, 2025, in Berlin, Germany (Press release, Catalym, SEP 22, 2025, View Source [SID1234656142]). Visugromab is a humanized, monoclonal antibody designed to neutralize the tumor-derived cytokine Growth Differentiation Factor-15 (GDF-15) that plays a central role in immune suppression and anti-PD(L)-1 treatment resistance.
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A late-breaking abstract featuring first results from the Phase 2 GDFATHER-NEO trial (NCT06059547) was accepted for oral presentation. The trial investigates visugromab as neoadjuvant treatment in combination with nivolumab in patients with muscle-invasive bladder cancer (MIBC) compared to nivolumab administered with placebo.
In addition, a second oral presentation will cover long-term follow-up data from the GDFATHER-01 Phase 1/2 trial (NCT04725474) demonstrating deep and durable remissions in heavily pretreated, anti-PD1/-L1 relapsed/refractory non-squamous non-small cell lung cancer (NSCLC), urothelial cancer (UC) and hepatocellular cancer (HCC) patients.
Presentation Details
Late-breaking Oral Presentation
Abstract Title: A blinded, exploratory phase 2 trial of nivolumab and the GDF-15 neutralizing antibody visugromab or placebo as neoadjuvant treatment of patients with muscle-invasive bladder cancer (MIBC): Primary results of the GDFATHER-NEO trial
Session Category & Title: Proffered paper session 1: GU tumours, renal & urothelial
Presentation Date & Time: October 17, 2025; 3:00 – 3:10 pm CEST
Presenter: Prof. Andrea Necchi, MD, Vita-Salute San Raffaele University, IRCCS San Raffaele Hospital
Location: Dortmund Auditorium – Hall 7.1a
Proffered Paper Presentation
Abstract Title: Long-term follow-up GDFATHER-01 trial: GDF-15 neutralization combined with nivolumab can enable deep, long-term remission in heavily pretreated, anti-PD1/-L1 relapsed/refractory non-squamous non-small cell lung cancer (NSCLC), urothelial cancer (UC) and hepatocellular cancer (HCC)
Session Category & Title: Proffered paper session: Investigational immunotherapy
Presentation Date & Time: October 20, 2025; 10:55 – 11:05 am CEST
Presenter: Prof. Ignacio Melero, MD, PhD, Co-Director of Immunology and Immunotherapy (CIMA) at the Universidad de Navarra, Pamplona/Spain
Location: Hanover Auditorium – Hall 7.2c
About Visugromab
Visugromab is a monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant produced by tumors which fosters immunotherapy resistance and drives cachexia in people with cancer. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by re-enabling immune cell activation, proliferation and induction of interferon-γ. In addition, visugromab also mitigates cancer cachexia, a severe condition affecting a significant number of advanced cancer patients by inhibiting the activation of the GFRAL pathway in the brainstem, a key driver of weight loss and appetite suppression in cancer patients.